Events

Arkon Anesthesia Delivery System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Del Mar Reynolds Medical, Ltd. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    77019
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2093-2017
  • 사례 시작날짜
    2017-04-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-10-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154830
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Gas-machine, anesthesia - Product Code BSZ
  • 원인
    Reports of the canister carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.
  • 조치
    Spacelabs sent an URGENT - MEDICAL DEVICE CORRECTION letter dated April 13, 2017, to US customers via priority service. The customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record on April 14, 2017. The letter announced that the The Arkon Anesthesia Delivery System, Model 99999, and the Absorber Adapter Assembly Kit part number 050-9045-00, and Absorber Adapter Assembly part number 650-1648-01 are being recalled. Customers are advised that The Arkon Anesthesia Delivery Systems Model 99999 with Absorber Adapter Assembly part number 650-1648-00 is NOT affected by this recall. Spacelabs Healthcare is developing a hardware upgrade to improve the robustness of the affected Absorber Adapter Assembly. A Spacelabs representative will contact consignees once the upgrade is available to schedule a convenient time to update their Arkon Anesthesia Delivery System(s) at no cost. For additional information or technical assistance, please contact: 1-800-522-7025 select 4 for Anesthesia Technical Support

Device

Arkon Anesthesia Delivery System
  • 모델명 / 제조번호(시리얼번호)
    *********the serial numbers and part numbers of units distributed in the US *********  Absorber Adapter Assembly Service Kit part number: 050-9045-00.  Devices serial numbers: ARKN-000395, ARKN-000396, ARKN-000397, ARKN-000398, ARKN-000399, ARKN-000400, ARKN-000401, ARKN-000402, ARKN-000403, ARKN-000404, ARKN-000405, ARKN-000406, ARKN-000407, ARKN-000408, ARKN-000409, ARKN-000410, ARKN-000411, ARKN-000412, and ARKN-000413.  *********the serial numbers of units distributed international **************************  ARKN-000375, ARKN-000414, ARKN-000415, ARKN-000416, ARKN-000417, ARKN-000418, ARKN-000419, ARKN-000420, ARKN-000421, ARKN-000422, and ARKN-000423.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.
  • 제품 설명
    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. || Absorber Adapter Assembly Service Kit, part number: 050-9045-00. || Absorber Adapter Assembly, part number: 650-1648-01. || Arkon Absorber Canister Carrier, part number: 380-0916-01.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.

Manufacturer

Del Mar Reynolds Medical, Ltd.
  • 제조사 주소
    Del Mar Reynolds Medical, Ltd., 1 2 Harforde Court John Tate Road, Business Park, Hertford United Kingdom
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA